Should all anticoagulated patients with head injury receive a CT scan? Decision-analysis modelling of an observational cohort

Objectives: It is not currently clear whether all anticoagulated patients with a head injury should receive CT scanning or only those with evidence of traumatic brain injury (e.g. loss of consciousness or amnesia). We aimed to determine the cost-effectiveness of CT for all compared to selective CT use for anticoagulated patients with a head injury. Design: Decision-analysis modelling of data from a multi-centre observational study. Setting: 33 Emergency Departments in England and Scotland. Participants: 3566 adults (aged ≥16 years) who had suffered blunt head injury, were taking warfarin and underwent selective CT scanning. Main outcome measures: Estimated expected benefits in terms of quality-adjusted life years (QALYs) were the entire cohort to receive a CT scan; estimated increased costs of CT and also the potential cost implications associated with patient survival and improved health. These values were used to estimate the cost per QALY of implementing a strategy of CT for all patients compared to observed practice based on guidelines recommending selective CT use. Results: Of the 1420/3534 patients (40%) who did not receive a CT scan, 7 (0.5%) suffered a potentially avoidable head injury related adverse outcome. If CT scanning had been performed in all patients, appropriate treatment could have gained 3.41 additional quality-adjusted life years (QALYs) but would have incurred £193,149 additional treatment costs and £130,683 additional CT costs. The incremental cost-effectiveness ratio of £94,895/QALY gained for unselective compared to selective CT use is markedly above the threshold of £20-30,000/QALY used by the UK National Institute for Care Excellence to determine cost-effectiveness. Conclusions: CT scanning for all anticoagulated patients with head injury is not cost-effective compared with selective use of CT scanning based on guidelines recommending scanning only for those with evidence of traumatic brain injur

AHEAD Study: an observational study of the management of anticoagulated patients who suffer head injury

OBJECTIVES: Management of anticoagulated patients after head injury is unclear due to lack of robust evidence. This study aimed to determine the adverse outcome rate in these patients and identify risk factors associated with poor outcome. DESIGN: Multicentre, observational study using routine patient records. SETTING: 33 emergency departments in England and Scotland. PARTICIPANTS: 3566 adults (aged ≥16 years) who had suffered blunt head injury and were currently taking warfarin. MAIN OUTCOME MEASURES: Primary outcome measure was rate of adverse outcome defined as death or neurosurgery following initial injury, clinically significant CT scan finding or reattendance with related complication within 10 weeks of initial hospital attendance. Secondary objectives included identifying risk factors for adverse outcome using univariable and multivariable analyses. RESULTS: Clinical data available for 3534/3566 patients (99.1%), median age 79 years; mean initial international normalised ratio (INR) 2.67 (SD 1.34); 81.2% Glasgow Coma Scale (GCS) 15: 59.8% received a CT scan with significant head injury-related finding in 5.4% (n=208); 0.5% underwent neurosurgery; 1.2% patients suffered a head injury-related death. Overall adverse outcome rate was 5.9% (95% CI 5.2% to 6.7%). Patients with GCS=15 and no associated symptoms had lowest risk of adverse outcome (risk 2.7%; 95% CI 2.1 to 3.6). Patients with GCS=15 multivariable analysis (using imputation) found risk of adverse outcome to increase when reporting at least one associated symptom: vomiting (relative risk (RR) 1.8; 95% CI 1.0 to 3.4), amnesia (RR 3.5; 95% CI 2.1 to 5.7), headache (RR 1.3; 95% CI 0.8 to 2.2), loss of consciousness (RR 1.75; 95% CI 1.0 to 3.0). INR measurement did not predict adverse outcome in patients with GCS=15 (RR 1.1; 95% CI 1.0 to 1.2). CONCLUSIONS: In alert warfarinised patients following head injury, the presence of symptoms is associated with greater risk of adverse outcome. Those with GCS=15 and no symptoms are a substantial group and have a low risk of adverse outcome. TRIAL REGISTRATION NUMBER: NCT02461498

Development of high-resolution infrared thermographic imaging method as a diagnostic tool for acute undifferentiated limp in young children

Acute limp is a common presenting condition in the paediatric emergency department. There are a number of causes of acute limp that include traumatic injury, infection and malignancy. These causes in young children are not easily distinguished. In this pilot study, an infrared thermographic imaging technique to diagnose acute undifferentiated limp in young children was developed. Following required ethics approval, 30 children (mean age = 5.2 years, standard deviation = 3.3 years) were recruited. The exposed lower limbs of participants were imaged using a high-resolution thermal camera. Using predefined regions of interest (ROI), any skin surface temperature difference between the healthy and affected legs was statistically analysed, with the aim of identifying limp. In all examined ROIs, the median skin surface temperature for the affected limb was higher than that of the healthy limb. The small sample size recruited for each group, however, meant that the statistical tests of significant difference need to be interpreted in this context. Thermal imaging showed potential in helping with the diagnosis of acute limp in children. Repeating a similar study with a larger sample size will be beneficial to establish reproducibility of the results

Implementing the National Institute for Health and Clinical Excellence Head Injury 2014 Guidelines in a major children’s hospital emergency department

Objectives and background Head injury is a common paediatric emergency department presentation. The National Institute for Health and Clinical Excellence updated its guidance in January 2014 regarding imaging required for adults and children following a head injury (CG176). This study looked at the rates of computed tomography (CT) head scans performed and adherence rates to CG176. Patients and methods A single-centre audit was carried out, examining imaging practice in children with head injuries. CG176 was implemented formally in August 2014 to the new trainee doctors. The primary outcome was adherence to CG176. As the data were binary, 95% confidence intervals were used for comparison. Results In all, 1797 patients were identified as having a head injury. Implementation at the Sheffield’s Children NHS Foundation Trust resulted in a statistically significant increase in guideline adherence from 79.2% [95% confidence interval (CI): 76.4–81.9%] to 85.1% (95% CI: 82.9–87.4%). The greatest impact in adherence was found in CT head scans, from 95.8% (95% CI: 94.5–97.2%) to 97.7% (95% CI: 96.7–98.6%). Conclusion The implementation at the Sheffield’s Children NHS Foundation Trust was successful in satisfying the aim of CG176 by increasing adherence and decreasing CT head scans. This success could be explained by the formal implementation to the new cohort of doctors and better physician agreement with the guidelines. The increase in adherence is contrary to the previous studies

Manifestations of Tuberculosis in Ear, Nose, Throat, Head and Neck Region – A Retrospective Study

Introduction  Tuberculosis can involve any organ or site. Otorhinolaryngologist may encounter tuberculosis affecting lymph nodes, ear, larynx, deep neck spaces, salivary glands etc. which can mimic other chronic granulomatous conditions or malignancy. To ensure early diagnosis, it is important to recognize its cardinal signs and symptoms and to be aware of potential pitfalls in diagnosis. This study was done to learn the clinical presentation of tuberculosis in ear, nose, throat and head and neck region, and to assess the effectiveness of various investigations and treatment done for the same. Materials and Methods  A retrospective study done in our institution involving 120 patients suffering from tuberculosis in ear, nose, throat and head and neck region who attended pulmonary medicine or ENT OPD or ward between January 2008 to December 2017 that is, 10 years. Study period for data collection and analysis was 1 month. Results Total 120 patients-69 males and 51 females. Most common site was cervical lymph nodes(77.5% patients), followed by larynx(8.3%),middle ear(7.5%),deep neck spaces(2.5%) and salivary glands and nose(1.7% each). Histopathology was highly sensitive(99. 1%).All except one patient responded to first-line antitubercular drugs, the other patient was given treatment for MDR-TB to which he responded. Conclusion Tuberculosis can involve any site in the head and neck region, most common being cervical lymph nodes mainly presenting as neck swelling. Variable nature of manifestations of tuberculosis makes it essential to have high degree of suspicion for early diagnosis

Emergency department clinical leads’ experiences of implementing primary care services where GPs work in or alongside emergency departments in the UK: a qualitative study

Background To manage increasing demand for emergency and unscheduled care NHS England policy has promoted services in which patients presenting to Emergency Departments (EDs) with non-urgent problems are directed to general practitioners (GPs) and other primary care clinicians working within or alongside emergency departments. However, the ways that hospitals have implemented primary care services in EDs are varied. The aim of this study was to describe ED clinical leads’ experiences of implementing and delivering ‘primary care services’ and ‘emergency medicine services’ where GPs were integrated into the ED team. Methods We conducted interviews with ED clinical leads in England (n = 19) and Wales (n = 2). We used framework analysis to analyse interview transcripts and explore differences across ‘primary care services’, ‘emergency medicine services’ and emergency departments without primary care services. Results In EDs with separate primary care services, success was reported when having a distinct workforce of primary care clinicians, who improved waiting times and flow by seeing primary care-type patients in a timely way, using fewer investigations, and enabling ED doctors to focus on more acutely unwell patients. Some challenges were: trying to align their service with the policy guidance, inconsistent demand for primary care, accessible community primary care services, difficulties in recruiting GPs, lack of funding, difficulties in agreeing governance protocols and establishing effective streaming pathways. Where GPs were integrated into an ED workforce success was reported as managing the demand for both emergency and primary care and reducing admissions. Conclusions Introducing a policy advocating a preferred model of service to address primary care demand was not useful for all emergency departments. To support successful and sustainable primary care services in or alongside EDs, policy makers and commissioners should consider varied ways that GPs can be employed to manage variation in local demand and also local contextual factors such as the ability to recruit and retain GPs, sustainable funding, clear governance frameworks, training, support and guidance for all staff. Whether or not streaming to a separate primary care service is useful also depended on the level of primary care demand

Distinct virologic trajectories in chronic hepatitis B identify heterogeneity in response to nucleos(t)ide analogue therapy

Background & Aims: The dynamics of HBV viral load (VL) in patients with chronic hepatitis B (CHB) on nucleos(t)ide analogue (NA) treatment and its relationship with liver disease are poorly understood. We aimed to study longitudinal VL patterns and their associations with CHB clinical outcomes. // Methods: Utilising large scale, routinely collected electronic health records from six centres in England, collated by the National Institute for Health and Care Research Health Informatics Collaborative (NIHR HIC), we applied latent class mixed models to investigate VL trajectory patterns in adults receiving NA treatment. We assessed associations of VL trajectory with alanine transaminase, and with liver fibrosis/cirrhosis. // Results: We retrieved data from 1,885 adults on NA treatment (median follow-up 6.2 years, IQR 3.7–9.3 years), with 21,691 VL measurements (median 10 per patient, IQR 5–17). Five VL classes were identified from the derivation cohort (n = 1,367, discrimination: 0.93, entropy: 0.90): class 1 ‘long term suppression’ (n = 827, 60.5%), class 2 ‘timely virological suppression’ (n = 254, 18.6%), class 3 ‘persistent moderate viraemia’ (n = 140, 10.2%), class 4 ‘persistent high-level viraemia’ (n = 44, 3.2%), and class 5 ‘slow virological suppression’ (n = 102, 7.5%). The model demonstrated a discrimination of 0.93 and entropy of 0.88 for the validation cohort (n = 518). Alanine transaminase decreased variably over time in VL-suppressed groups (classes 1, 2, 5; all p <0.001), but did not significantly improve in those with persistent viraemia (classes 3, 4). Patients in class 5 had twofold increased hazards of fibrosis/cirrhosis compared with class 1 (adjusted hazard ratio, 2.00; 95% CI, 1.33–3.02). // Conclusions: Heterogeneity exists in virological response to NA therapy in CHB patients, with over 20% showing potentially suboptimal responses. Slow virological suppression is associated with liver disease progression. // Impact and implications Treatment recommendations for people living with chronic hepatitis B virus (HBV) infection are becoming less stringent, meaning that more of the population will be eligible to receive therapy with nucleos(t)ide analogue agents. We explored outcomes of HBV treatment in a large UK dataset, describing different responses to treatment, and showing that the viral load is not completely suppressed after 1 year in about one in five cases, associated with an increased risk of liver complications. As treatment is rolled out more widely, patients and clinicians need to be aware of the potential for incomplete virologic responses. The findings can support the identification of high-risk individuals, improve early fibrosis and cirrhosis prediction, guide monitoring and preventive interventions, and support public health elimination goals

Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial

Background Tranexamic acid reduces surgical bleeding and decreases mortality in patients with traumatic extracranial bleeding. Intracranial bleeding is common after traumatic brain injury (TBI) and can cause brain herniation and death. We aimed to assess the effects of tranexamic acid in patients with TBI. Methods This randomised, placebo-controlled trial was done in 175 hospitals in 29 countries. Adults with TBI who were within 3 h of injury, had a Glasgow Coma Scale (GCS) score of 12 or lower or any intracranial bleeding on CT scan, and no major extracranial bleeding were eligible. The time window for eligibility was originally 8 h but in 2016 the protocol was changed to limit recruitment to patients within 3 h of injury. This change was made blind to the trial data, in response to external evidence suggesting that delayed treatment is unlikely to be effective. We randomly assigned (1:1) patients to receive tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Patients were assigned by selecting a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was head injury-related death in hospital within 28 days of injury in patients treated within 3 h of injury. We prespecified a sensitivity analysis that excluded patients with a GCS score of 3 and those with bilateral unreactive pupils at baseline. All analyses were done by intention to treat. This trial was registered with ISRCTN (ISRCTN15088122), ClinicalTrials.gov (NCT01402882), EudraCT (2011-003669-14), and the Pan African Clinical Trial Registry (PACTR20121000441277). Results Between July 20, 2012, and Jan 31, 2019, we randomly allocated 12 737 patients with TBI to receive tranexamic acid (6406 [50·3%] or placebo [6331 [49·7%], of whom 9202 (72·2%) patients were treated within 3 h of injury. Among patients treated within 3 h of injury, the risk of head injury-related death was 18·5% in the tranexamic acid group versus 19·8% in the placebo group (855 vs 892 events; risk ratio [RR] 0·94 [95% CI 0·86-1·02]). In the prespecified sensitivity analysis that excluded patients with a GCS score of 3 or bilateral unreactive pupils at baseline, the risk of head injury-related death was 12·5% in the tranexamic acid group versus 14·0% in the placebo group (485 vs 525 events; RR 0·89 [95% CI 0·80-1·00]). The risk of head injury-related death reduced with tranexamic acid in patients with mild-to-moderate head injury (RR 0·78 [95% CI 0·64-0·95]) but not in patients with severe head injury (0·99 [95% CI 0·91-1·07]; p value for heterogeneity 0·030). Early treatment was more effective than was later treatment in patients with mild and moderate head injury (p=0·005) but time to treatment had no obvious effect in patients with severe head injury (p=0·73). The risk of vascular occlusive events was similar in the tranexamic acid and placebo groups (RR 0·98 (0·74-1·28). The risk of seizures was also similar between groups (1·09 [95% CI 0·90-1·33]). Interpretation Our results show that tranexamic acid is safe in patients with TBI and that treatment within 3 h of injury reduces head injury-related death. Patients should be treated as soon as possible after injury. Funding National Institute for Health Research Health Technology Assessment, JP Moulton Charitable Trust, Department of Health and Social Care, Department for International Development, Global Challenges Research Fund, Medical Research Council, and Wellcome Trust (Joint Global Health Trials scheme)